MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-12-27 for LAMINARIA 021003 manufactured by Medgyn Products, Inc..
[4219102]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11475510]
Medwatch report sent to us reporting that laminaria broke off in a pt during removal. Pt required general anesthesia and operative laparoscopy to remove fragments. An investigation was performed. A review of dhr documents and a review of complaints of similar issues was performed, there were no signs of imperfection, damage or broken laminaria as the nature of complaint is isolated. It cannot be conclusively investigated and no probable product defect can be assigned. Our investigation reveals that there is no weakness in this lot of laminaria. The incident was precipitated by wrongful use of the string to pull the laminaria out of the cervix. Recommended forceps use may have prevented this incident. Summary: we have not heard from the initial reporter about this incident. The report was received in the form of medwatch from fda. We have not had any similar reports on laminaria prior to this time. Our instructions for use (see attached) does recommend against usage of the string in withdrawing swollen laminaria from the cervix. The removal should be achieved by grasping the laminaria by hand or using grasping forceps to gently ease out the expanded laminaria. Laminaria when swollen has a soft texture and an attempt by the medical practitioner to pull the string will cut through the soft laminaria. Gentle use of forceps to ease out the laminaria may have helped in the removal without incident. Alternatively, use of a vacuum pump with a vacurette may also have aided removal of the swollen soft laminaria from the cervix. The vacurette may even have helped removal of the laminaria after the string got pulled away. Final conclusion: as the nature of complaint is isolated, it cannot be conclusively investigated and no probable product defect can be established or assigned. The issue will be continued to be monitored as more info is obtained. No corrective action will be issued at this stage. A mandatory mfr medwatch report is being filed. Our investigation reveals that there is no weakness in this lot of laminaria. The incident was precipitated by wrongful use of the string to pull the laminaria out of the cervix. Recommended forceps use may have prevented this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450908-2013-00001 |
| MDR Report Key | 3553990 |
| Report Source | 00 |
| Date Received | 2013-12-27 |
| Date of Report | 2013-11-08 |
| Date of Event | 2013-10-29 |
| Report Date | 2013-11-01 |
| Date Reported to FDA | 2013-11-01 |
| Date Mfgr Received | 2013-11-29 |
| Device Manufacturer Date | 2011-06-16 |
| Date Added to Maude | 2014-01-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SHIVASHANKAR |
| Manufacturer Street | 100W INDUSTRIAL RD |
| Manufacturer City | ADDISON IL 60101 |
| Manufacturer Country | US |
| Manufacturer Postal | 60101 |
| Manufacturer Phone | 6306274105 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAMINARIA |
| Generic Name | LAMINARIA |
| Product Code | HDY |
| Date Received | 2013-12-27 |
| Catalog Number | 021003 |
| Lot Number | 061611 |
| Device Expiration Date | 2016-05-01 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDGYN PRODUCTS, INC. |
| Manufacturer Address | 100 W INDUSTRIAL RD ADDISON IL 60101 US 60101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-27 |